Clinical Trial: Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Prospective, Randomized, Open-label, Controlled Trial of Cyclooxygenase-2 Inhibitor (Celecoxib; Celebrex®) for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer.
Brief Summary: In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.
Detailed Summary:
Patients : total 220 patients
- Extrahepatic bile duct cancer : 55 patients for administration of COX2 55 patients for control group
- Pancreas cancer : 55 patients for administration of COX2 55 patients for control group
Indication
- After operation of extrahepatic bile duct cancer or pancreas cancer
- Age : 19 - 70 years old
- The patients who agree to consent sheet.
Contraindication
- Impossible of administration due to severe postoperative morbidities (bleeding, bowel obstruction, pancreatic fistula, biliary fistula)
- Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP>160)
- Renal insufficiency: CCR < 50 or serum creatinin >3.0
- Hepatic insufficiency: Liver cirrhosis or active hepatitis
- Preexisting allergic reaction history for NSAIDs or Sulfonamide
- Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
- Preexisting Asthma. Especially aspirin-sensitive asthma.
- Contraindications to aspirin, clopidogrel or celecoxib
- The patients who refuse trial
- The patients who has Psychogenic problem
Allocation
- Recurrent rate and survival rate
Original Primary Outcome:
- Safety [ Time Frame: 2 years ]Number of participants with adverse events Kinds of adverse events
- Short term outcome [ Time Frame: 2 years ]Recurrent rate and survival rate
Current Secondary Outcome: Long term outcome [ Time Frame: 4 years ]
Original Secondary Outcome: Long term outcome (survival rate, recurrence rate) [ Time Frame: 4 years ]
Information By: Seoul National University Hospital
Dates:
Date Received: March 31, 2009
Date Started: November 2008
Date Completion: June 2017
Last Updated: October 27, 2016
Last Verified: October 2016